SENSOR DEVELOPMENT AND VALIDATION RELEASE DATE: February 25, 2002 RFA: RFA-EB—02-002 PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov) National Human Genome Research Institute (NHGRI) (http://www.nhgri.nih.gov/) National Institute on Deafness and Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/) National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) LETTER OF INTENT RECEIPT DATE: March 29, 2002 APPLICATION RECEIPT DATE: April 24, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations: PURPOSE OF THIS RFA The National Institute of Biomedical Imaging and Bioengineering (NIBIB), the National Human Genome Research Institute (NHGRI)the National Institute on Deafness and Communication Disorders (NIDCD), the National Institute of Dental and Craniofacial Research (NIDCR), and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite applications for NIH Research Project Grants (R01) or Phased Innovation Awards (R21/R33) in sensor development and validation. NIBIB is soliciting research that can be applied to multiple biological or disease processes. The NIDCD is interested in sensor systems pertaining to the auditory, vestibular, olfactory, taste, voice, speech and language neural and sensory systems. The NIDCR is interested in the development of sensor system for simultaneous multi- analyte detection in saliva and other oral fluids. NIDDK is soliciting projects focused on continuous and/or noninvasive glucose measurement, as well as research to incorporate glucose sensors into closed-loop insulin delivery systems for management of diabetes. The purpose of this Request for Applications (RFA) is to support innovative basic and applied research targeted at sensor development including sensor arrays, their biointerfaces, quality control issues, validation and data interpretation. Multidisciplinary approaches are encouraged that involve disciplines such as materials engineering, biochemistry, mathematics, computer science, electrical engineering, physiology, medicine, bioengineering and physics. Biorecognition elements in combination with various transduction methods have enabled major advancements in the development of sensors and chips. In addition, recent enhancements have enabled the merging of functions for computation, communication and power source together with sensor and actuator. To move these technologies into the clinical situation, certain impediments must be addressed. In particular, this initiative encourages research to address: o integration of sensors to obtain multiplexed functionality, o sensor interface and related algorithm development to relate sensor output to physiologically relevant or clinically relevant parameters, o biofouling of sensors, and o sensor system and data validation. RESEARCH OBJECTIVES Biology and medicine have gained enormous insight into the life process by discovery, development and application of sensors. Such sensors have enabled discoveries relating to DNA, RNA and protein synthesis, cell organelle function, tissue organization and organ system integration in normal and diseased states. This information has enabled researchers to develop new methods for the prevention, diagnosis and treatment of diseases. While these developments have been extraordinary, future breakthroughs will depend on improvements in sensor technology. In particular, sensor advancements will be achieved with methods to prevent biofouling, to integrate sensors to obtain multiplexed functionality, to develop algorithms to relate sensor output to physiologically relevant or clinically relevant parameters and validation of sensors systems. Biological sensor systems have demonstrated the complexity and the simplicity of nature. The olfactory system reveals a strategy that is complementary to the conventional chemical sensing approach but involves the use of sensor arrays. Olfactory receptors are not highly selective toward specific analytes but rather one receptor responds to many analytes and many receptors respond to any given analyte. Thus, sensor arrays do not require the high specificity of an individual sensor. Identification of an analyte is determined by a distinct pattern of responses over the sensor array (fingerprint) rather then the response of a single sensor element. Sensor arrays would be a significant improvement over conventional sensors. Sensors that are placed in a solution or a human will have a corruption of the signal and will eventually fail due to biofouling. Biofouling is the rapid accumulation of adsorbed material on the working surface of the sensor. This problem makes long-term monitoring difficult and requires frequent maintenance operations and probe replacement. Biofouling is found to occur in every monitoring technique that operates in situ (electrochemical, optical electrical, thermal, etc.). Techniques to overcome biofouling are urgently needed. Validation of sensor measurements is an integral step in the application of sensor technology. The sensor measurements must be shown to be consistent even under changing conditions of operation, e.g., in vivo, temperature, pH, ion concentration, etc. While sensor redundancy is one method for addressing validation, this method has disadvantages. In general any validation method must address the sensor function in real time. Once the sensor data has been validated, it is essential to relate the sensor output to a physiologically relevant or clinically meaningful value(s). The relationship between the sensor measurement and the clinical parameter(s) must be clearly defined. Algorithm(s) must be developed to relate sensor measurements to these parameters. For example, the relationship between a sensor output and blood glucose must be known in order to regulate insulin delivery in response to a glucose measurement made in the interstitium. Utilization of sensors without validation and without a clear understanding of the relationship of the data to the parameter(s) of interest is inappropriate application of sensor technology. The objectives and scope of this initiative are to support basic and applied research for the discovery of novel sensor technology and the enhancement of sensor utilization in research, clinical investigations and disease management. Irrespective of a sensor"s detection system or the measured parameter(s), certain basic issues will have to be addressed for successful sensor advances. These issues include biofouling, data validation and algorithm determination. Innovative approaches to address any or all of these issues are within the scope of this initiative. In addition, or alternatively, utilization of novel sensor array technologies would be appropriate. Research topics might include but are not limited to the following: o Construction of sensor arrays, o Development of multi-modality sensor arrays, o Development of biomimetic materials that will reduce or prevent biofouling, o Design of a sensor surface that is impregnated with compounds to alter the immune response or enhance wound repair, o Development of robust data validation methods that are applicable to a wide range of sensor modalities, o Development of approaches to relate sensor output to clinical parameters, o Design of models to relate the sensor"s physical response characteristics to data integrity, o Development of sensor quality control systems in real time, o Utilization of prediction models to measure sensor drift or identify incorrect data, o Construction of the computer interface, sensor control software, and data processing software to link sensor array output to a clinical parameter, o Development of biological based high throughput sensor technologies using organism specific markers for the detection of middle ear infections, o Development of electrostimulatory prostheses capable of sensing head acceleration forces to improve the balance of vestibular-deficient individuals, o Development and enhancement of sensor technology for the improved detection of odor and taste substances, o Development of sensor arrays for simultaneous analyte detection in saliva and other oral fluids, o Development and evaluation of novel continuous and/or noninvasive glucose sensors, and o Development of approaches to link glucose sensing to insulin systems in a closed-loop system for the treatment of diabetes o Development of the neural tissue and circuitry hardware interface(s) to improve amplification and transmission of sound and speech. The overall objective of this RFA is to provide flexible funding mechanisms to support the research activities required to discover, develop and validate innovative sensor approaches. MECHANISM OF SUPPORT This RFA will use the NIH Research Project Grant (R01) and Phased Innovation Award (R21/R33) mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2002. This RFA uses just-in-time concepts. Applications for the R01 mechanism use the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting a R01 application with direct costs in each year of $250,000 or less, the modular format should be used. Otherwise follow the instructions for non-modular research grant applications. For this RFA, applications for R21/R33 grants should use the detailed budget (non-modular) format only. The R01 mechanism is recommended for applications that emphasize basic research on sensor arrays, glucose sensors, their biointerfaces, quality control issues and validation. Research periods associated with the R01 proposals are limited to five years. The R21/R33 Phased Innovation Award is recommended for system engineering approaches such as the development and integration of sensors that can be applied to multiple biological or disease processes, incorporation of glucose sensors into closed-loop systems, or partnerships with industry for technology development and dissemination. The combined R21/R33 application offers two advantages over the regular application process – (1) single submission and evaluation of both the R21 and R33 phases as one application and (2) minimal or no funding gap between the R21 and R33 phases. A single application for the combined R21 and R33 phases with a total period of up to five years is required for this initiative. The R21 phase supports exploratory or developmental research aimed at proof-of- principle for high-risk projects where preliminary data is not available. An R21 application can be for one to two years with a maximum budget request of $150,000 direct costs per year. The R33 mechanism supports the second phase of the innovative exploratory or developmental research initiated under the R21 mechanism. A R33 application can be for one to four years with a maximum budget request of $500,000 direct costs per year. Transition from the R21 to the R33 phase is dependent on successful completion of milestones specified in the R21 application as determined by program staff in the context of peer review recommendations. The R21 application must include milestones that will be used to judge the success of the proposed exploratory research. The Phased Innovation Award application must have a section titled "Milestones" at the end of the Research Plan for the R21 application. This section must propose well-defined, quantifiable milestones for the completion of the R21 phase, a discussion of the suitability of the proposed milestones for assessing the success of the R21 research, and a discussion of the implications of successful completion of these milestones for the R33 phase. FUNDS AVAILABLE The NIBIB, NHGRI, NIDCD, NIDCR and NIDDK intend to commit approximately $6.9 million in FY 2002 to fund new grants in response to this RFA. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the FY 2002 financial plans of the NIBIB, the NIDCD and the NIDDK provide support for this program, awards pursuant to the RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organization o Public or private institutions such as universities, colleges, hospitals, and laboratories o National laboratories o Units of state and local governments o Eligible agencies of the Federal government o Domestic or foreign INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Joan T. Harmon, Ph.D. Acting Director Division of Bioengineering National Institute of Biomedical Imaging and Bioengineering Building 31, Room 1B37 Bethesda, MD 20892 Telephone: (301) 451-6772 FAX: (301) 480-4515 Email: joan_harmon@nih.gov Jeffery A. Schloss, Ph.D. Division of Extramural Research National Human Genome Research Institute Building 31, Room B2.B07 Bethesda, MD 20892-2033 Telephone: (301)496-7531 FAX: (301)480-2770 Email: jeff_schloss@nih.gov Nancy L. Freeman, Ph.D. Scientific Program Director National Institutes of Health National Institute on Deafness and Other Communication Disorders Executive Plaza South-400C 6120 Executive Blvd. MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3458 Fax: (301) 402-6251 Email: nancy_freeman@NIH.gov Maren R. Laughlin, Ph.D. Director, Metabolism Program National Institute of Diabetes and Digestive and Kidney Diseases 2 Democracy Plaza, 6707 Democracy Blvd., Room 6101, MSC 5460 Bethesda, MD 20892-5460 Telephone: (301)594-8802 FAX: (301) 480-3503 Email: Maren.Laughlin@nih.gov Eleni Kousvelari, DDS, D.Sc. Biotechnology and Biomaterials Program Cellular & Molecular Biology, Physiology & Biotechnology Branch Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research Building 45 Room 4AN-18A Bethesda, MD 20892 Telephone: (301) 594-2427 FAX: (301) 480-8318 Email: eleni.kousvelari@nih.gov o Direct your questions about peer review issues to: Calbert Laing, Ph.D. Chief Immunological Sciences Integrated Review Group Center for Scientific Review Building RKL2, Room 4210 Bethesda, MD 20892 Telephone: (301) 435-1221 FAX: (301) 480-4045 Email: laingc@csr.nih.gov o Direct your questions about financial or grants management matters to: Ms. Annette Hanopole Grants Management Officer National Institute of Biomedical Imaging and Bioengineering Building 31, Room 1B37 Bethesda, MD 20892-2077 Telephone: 301-451-6768 Fax: 301-480-4515 Email: hanopola@nibib.nih.gov Jean Cahill Grants Administration Branch National Human Genome Research Institute Building 31, Room B2.B34 Bethesda, MD 20892-2031 Telephone: (301) 402-0733 FAX: (301) 402-1951 Email: jc166o@nih.gov Sara Stone Chief, Grants Management Branch NIH/NIDCD Executive Plaza South, Room 400B 6120 Executive Boulevard, MSC-7180 Bethesda, MD 20892 Telephone: (301) 402-0909 Fax: (301) 402-1758 Email: sara_stone@nih.gov Ms. Denise Payne Grants Management Specialist National Institute of Diabetes and Digestive and Kidney Diseases 2 Democracy Plaza, 6707 Democracy Blvd., Room 733, MSC 5456 Bethesda, MD 20892-5456 Telephone: (301)594-8845 FAX: (301) 480-3504 Email: payned@extra.niddk.nih.gov H. George Hausch, Ph.D. Acting Director, Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health 45 Center Drive, Room 4AN-44F Bethesda, MD 20892-6402 Telephone: (301) 594-2904 FAX: (301) 480-8303 Email: George.Hausch@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIBIB and CSR staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. It is preferred that the letter of intent be sent electronically to noi@nibib.nih.gov. If necessary, the letter of intent can be sent by regular mail to Dr. Joan T. Harmon, listed in the WHERE TO SEND INQUIREIES section of this announcement. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and five signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIBIB. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the CSR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate Institute Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? To what degree does the technology support the needs for research on biological or disease processes? (2) APPROACH: Are the conceptual framework, design, and methods adequately developed, well integrated, and appropriate for (l) cross- cutting fundamental discovery (R01) or (2) technology and tool development (R21/R33)? Does the applicant acknowledge potential problem areas and consider alternative tactics? If appropriate, what is the time frame for developing the proposed technologies or tools, and what is the suitability of this time frame for meeting the community"s needs? How easy will it be to use the proposed technology or tools? Are the plans adequate for integrating the proposed technology as an effective solution for implementation and dissemination? If industrial partnerships are proposed, how will they facilitate and complement the technology and tool development? (3) INNOVATION: Does the project address discovery or technology/tool development that represents innovation for the field? Does the project challenge existing paradigms or employ novel concepts, approaches, or methods? What are the innovative applications of the proposed fundamental discovery, technology, or tools? (4) INVESTIGATOR: Does the principal investigator possess appropriate experience and capabilities to direct and carry out this work? Is the experience level of the principal investigator, other researchers, or collaborators appropriate for the proposed effort? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support or collaborative agreements? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o MILESTONES FOR COMBINED R21/R33 APPLICATIONS: For the R21/R33 applications, how appropriate are the proposed milestones for evaluating the demonstration of feasibility for the R21 effort and transition to the R33 development phase? For R21/R33 Phased Innovation Award applications, the scientific review group will evaluate the specific goals of each phase and the feasibility milestones that would justify progression to the R33 phase. A single priority score will be assigned to each scored application. As with any grant application, the scientific review group has the option of recommending support for a shorter duration than that requested by the applicant, and basing the final merit rating on the recommended portion of the application. This may result in a recommendation that only the R21 phase of the combined R21/R33 application be supported based on the relative merit of the two research plans, adequacy of the milestones for determining success of the R21 feasibility studies, and capacity to provide easily assessed justification for progression to the R33 phase without further review. The scientific review group may recommend modifications to or the addition of milestones. Deletion of the R33 phase by the review panel or inadequate milestones may affect the rating of the application. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 29, 2002 Application Receipt Date: April 24, 2002 Peer Review Date: June/July 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub- populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this initiative in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.287 (NIBIB), No. 93.172 (NHGRI), No. 93.173 (NIDCD), No. 93.173 (NIDCR) and No. 93.847 (NIDDK) and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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